BARCELONA — The long-awaited 5-year survival analysis from the Clinical Outcomes of Surgical Therapy trial indicate that laparoscopic colectomy is clinically equivalent to open abdominal surgery as a treatment for colon cancer and has advantages for quality of life, Dr. Heidi Nelson said at the 14th European Cancer Conference.
The National Cancer Institute-funded Clinical Outcomes of Surgical Therapy (COST) study began in the mid-1990s, largely in response to a 1994 statement by the American Society of Colorectal Surgeons that “absence of 5-year data makes it premature to endorse this procedure [laparoscopic colectomy].”
The numbers are now in, and “we can now say that Level 1 evidence supports the practice of laparoscopic colectomy,” said Dr. Nelson, a colorectal surgeon at the Mayo Clinic, Rochester, Minn.
The trial protocol randomized 872 people with stage I-III colon cancer to either open surgery or laparoscopic colectomy, performed by well-credentialed laparoscopic surgeons at major U.S. cancer hospitals. All procedures were videotaped and archived, as were histologic samples of tumor tissue.
Initial survival data were first published in 2004, and showed no difference in clinical outcomes between the two procedures (N. Engl. J. Med. 2004;350:2050–9). However, in terms of quality of life, length of hospital stay, and pain, the scope-based procedures were clearly superior.
The 5-year survival data echo those earlier findings, Dr. Nelson said at the conference, sponsored by the Federation of European Cancer Societies. “The curves are completely overlapping. There is no significant difference in terms of overall survival or disease-free survival. The cumulative incidence of recurrence was low in both treatment arms. There is no real evidence of a clinical advantage of one procedure over the other.”
After a median of 7 years' follow-up, 75% of the laparoscopic surgery patients and 77% of the open surgery patients were still alive. Disease-free survival was equal, at 69%, and local recurrence rates were very low at 2.6% in the laparoscopic group and 2.3% in the open surgery group.
Dr. Nelson noted that there seemed to be a slight statistical advantage of open procedures for overall survival of stage I patients. But this finding is difficult to interpret because most of the deaths in patients with stage I tumors were not cancer related.
The procedures were equivalent in terms of treatment-related morbidity and complication rates, which were low in both groups.
Laparoscopic colectomy had clear advantages in terms of quality of life; for example, the total mean incision lengths were 60 mm for laparoscopic surgery and 180 mm for open surgery.
Mean length of stay was 5 days for the laparoscopically treated patients vs. 6 days for open surgery patients, a 20% decrease with significant fiscal implications given the high cost of hospitalization. Laparoscopically treated patients also used fewer painkillers.
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